Comparison of Single-Layer and Triple-Layer TPU MaxFlex Aligners After Intraoral Use (NCT07566533) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Single-Layer and Triple-Layer TPU MaxFlex Aligners After Intraoral Use
Pakistan66 participantsStarted 2025-09-13
Plain-language summary
This study aims to compare two types of clear orthodontic aligner materials used in dental treatment: single-layer and triple-layer thermoplastic polyurethane (TPU) aligners (MaxFlex). Clear aligners are commonly used to straighten teeth and are preferred for their comfort and aesthetic appearance.
Participants will be provided with aligners and instructed to wear them for approximately 22 hours per day for 10 days. The aligners will be collected before use and after the 10-day period. The study will evaluate how the oral environment affects the properties of these materials over time.
Laboratory tests will be conducted to measure mechanical properties such as strength, flexibility, and deformation, as well as to examine surface changes under a microscope. The results of this study may help improve the performance and durability of aligners and contribute to better orthodontic treatment outcomes.
Who can participate
Age range
18 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients aged 18-30 years Fully erupted permanent dentition Good periodontal health Patients undergoing orthodontic treatment with clear aligners Mild crowding or spacing requiring labiolingual tooth movement Willingness to wear aligners for at least 22 hours per day Provision of informed consent
Exclusion Criteria:
Use of aligners from manufacturers other than study-specific TPU aligners Damaged or fractured aligners Poor compliance (wear time less than 22 hours/day) Presence of parafunctional habits (e.g., bruxism) Hypodontia or partially erupted dentition Cases involving bonded attachments on maxillary incisors Cases requiring rotational movement of maxillary incisors Patients with systemic or oral conditions affecting saliva composition or the oral environment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect of Oral Environment on Elastic Modulus of TPU Aligners
Timeframe: Baseline (0 week) and after 2 weeks of intraoral use (minimum 22 hours/day)
2
Effect of Oral Environment on Stress Relaxation of TPU Aligners
Timeframe: Time Frame: Baseline (0 week) and after 2 weeks of intraoral use (minimum 22 hours/day)
3
Effect of Oral Environment on Creep Behavior of TPU Aligners
Timeframe: Time Frame: Baseline (0 week) and after 2 weeks of intraoral use (minimum 22 hours/day)